FDA advisers recommend Novavax COVID vaccine for emergency use

With nearly 22% of the nation yet to receive a single COVID-19 vaccine dose, federal vaccine advisers today recommended that the Novavax COVID-19 vaccine be approved under an emergency use authorization (EUA).If the Food and Drug Administration (FDA) accepts the group's recommendation and Centers for Disease Control and Prevention (CDC) advisers recommend it, Novavax would give the United States a fourth vaccine to battle the virus.

The Novavax vaccine is already approved for emergency use in other countries, and US officials hope that a vaccine made with a more traditional process might sway some who have been hesitant to be immunized against COVID-19.In other US developments, the CDC today said the BA.4 and BA.5 Omicron subvariants are starting to become more prevalent across the country, and a new survey of US public schools found that rural and lower income schools were less likely than others to make ventilation improvements to reduce the spread of COVID-19.Uncertainty about Omicron protection, heart effectsDuring today's meeting, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was asked to weigh the benefits and risks in people ages 18 and older.

The Novavax vaccine is a recombinant nanoparticle protein-based product that contains an adjuvant. It is given in two doses, 3 weeks apart.

The measure passed with 21 yes votes and 1 abstention.Ahead of the meeting last week, FDA staff published an extensive review of the vaccine's efficacy and safety, which said the vaccine—largely studied when the Alpha variant was circulating—would probably provide meaningful protection against the Omicron variant, though they raised concerns for rare cardiac conditions after vaccination, similar to ones that